[Congressional Record (Bound Edition), Volume 154 (2008), Part 4]
[House]
[Pages 5390-5394]
[From the U.S. Government Publishing Office, www.gpo.gov]




               NEWBORN SCREENING SAVES LIVES ACT OF 2007

  Mrs. CAPPS. Madam Speaker, I move to suspend the rules and pass the 
Senate bill (S. 1858) to amend the Public Health Service Act to 
establish grant programs to provide for education and outreach on 
newborn screening and coordinated followup care once newborn screening 
has been conducted, to reauthorize programs under part A of title XI of 
such Act, and for other purposes.
  The Clerk read the title of the Senate bill.
  The text of the Senate bill is as follows:

                                S. 1858

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Newborn Screening Saves 
     Lives Act of 2007''.

     SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE 
                   DISORDER.

       Section 1109 of the Public Health Service Act (42 U.S.C. 
     300b-8) is amended--
       (1) by striking subsections (a), (b), and (c) and inserting 
     the following:
       ``(a) Authorization of Grant Program.--From amounts 
     appropriated under subsection (j), the Secretary, acting 
     through the Administrator of the Health Resources and 
     Services Administration (referred to in this section as the 
     `Administrator') and in consultation with the Advisory 
     Committee on Heritable Disorders in Newborns and Children 
     (referred to in this section as the `Advisory Committee'), 
     shall award grants to eligible entities to enable such 
     entities--
       ``(1) to enhance, improve or expand the ability of State 
     and local public health agencies to provide screening, 
     counseling, or health care services to newborns and children 
     having or at risk for heritable disorders;
       ``(2) to assist in providing health care professionals and 
     newborn screening laboratory personnel with education in 
     newborn screening and training in relevant and new 
     technologies in newborn screening and congenital, genetic, 
     and metabolic disorders;
       ``(3) to develop and deliver educational programs (at 
     appropriate literacy levels) about newborn screening 
     counseling, testing, follow-up, treatment, and specialty 
     services to parents, families, and patient advocacy and 
     support groups; and
       ``(4) to establish, maintain, and operate a system to 
     assess and coordinate treatment relating to congenital, 
     genetic, and metabolic disorders.

[[Page 5391]]

       ``(b) Eligible Entity.--In this section, the term `eligible 
     entity' means--
       ``(1) a State or a political subdivision of a State;
       ``(2) a consortium of 2 or more States or political 
     subdivisions of States;
       ``(3) a territory;
       ``(4) a health facility or program operated by or pursuant 
     to a contract with or grant from the Indian Health Service; 
     or
       ``(5) any other entity with appropriate expertise in 
     newborn screening, as determined by the Secretary.
       ``(c) Approval Factors.--An application submitted for a 
     grant under subsection (a)(1) shall not be approved by the 
     Secretary unless the application contains assurances that the 
     eligible entity has adopted and implemented, is in the 
     process of adopting and implementing, or will use amounts 
     received under such grant to adopt and implement the 
     guidelines and recommendations of the Advisory Committee that 
     are adopted by the Secretary and in effect at the time the 
     grant is awarded or renewed under this section, which shall 
     include the screening of each newborn for the heritable 
     disorders recommended by the Advisory Committee and adopted 
     by the Secretary.'';
       (2) by redesignating subsections (d) through (i) as 
     subsections (e) through (j), respectively;
       (3) by inserting after subsection (c), the following:
       ``(d) Coordination.--The Secretary shall take all necessary 
     steps to coordinate programs funded with grants received 
     under this section and to coordinate with existing newborn 
     screening activities.''; and
       (4) by striking subsection (j) (as so redesignated) and 
     inserting the following:
       ``(j) Authorization of Appropriations.--There is authorized 
     to be appropriated--
       ``(1) to provide grants for the purpose of carrying 
     activities under section (a)(1), $15,000,000 for fiscal year 
     2008; $15,187,500 for fiscal year 2009, $15,375,000 for 
     fiscal year 2010, $15,562,500 for fiscal year 2011, and 
     $15,750,000 for fiscal year 2012; and
       ``(2) to provide grant for the purpose of carrying out 
     activities under paragraphs (2), (3), and (4) of subsection 
     (a), $15,000,000 for fiscal year 2008, $15,187,500 for fiscal 
     year 2009, $15,375,000 for fiscal year 2010, $15,562,500 for 
     fiscal year 2011, and $15,750,000 for fiscal year 2012.''.

     SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN AND CHILD 
                   SCREENING PROGRAMS.

       Section 1110 of the Public Health Service Act (42 U.S.C. 
     300b-9) is amended by adding at the end the following:
       ``(d) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section 
     $5,000,000 for fiscal year 2008, $5,062,500 for fiscal year 
     2009, $5,125,000 for fiscal year 2010, $5,187,500 for fiscal 
     year 2011, and $5,250,000 for fiscal year 2012.''.

     SEC. 4. ADVISORY COMMITTEE ON HERITABLE DISORDERS IN NEWBORNS 
                   AND CHILDREN.

       Section 1111 of the Public Health Service Act (42 U.S.C. 
     300b-10) is amended--
       (1) in subsection (b)--
       (A) by redesignating paragraph (3) as paragraph (6);
       (B) in paragraph (2), by striking ``and'' after the 
     semicolon;
       (C) by inserting after paragraph (2) the following:
       ``(3) make systematic evidence-based and peer-reviewed 
     recommendations that include the heritable disorders that 
     have the potential to significantly impact public health for 
     which all newborns should be screened, including secondary 
     conditions that may be identified as a result of the 
     laboratory methods used for screening;
       ``(4) develop a model decision-matrix for newborn screening 
     expansion, including an evaluation of the potential public 
     health impact of such expansion, and periodically update the 
     recommended uniform screening panel, as appropriate, based on 
     such decision-matrix;
       ``(5) consider ways to ensure that all States attain the 
     capacity to screen for the conditions described in paragraph 
     (3), and include in such consideration the results of grant 
     funding under section 1109; and'';
       (D) in paragraph (6) (as so redesignated by subparagraph 
     (A)), by striking the period at the end and inserting ``, 
     which may include recommendations, advice, or information 
     dealing with--
       ``(A) follow-up activities, including those necessary to 
     achieve rapid diagnosis in the short-term, and those that 
     ascertain long-term case management outcomes and appropriate 
     access to related services;
       ``(B) implementation, monitoring, and evaluation of newborn 
     screening activities, including diagnosis, screening, follow-
     up, and treatment activities;
       ``(C) diagnostic and other technology used in screening;
       ``(D) the availability and reporting of testing for 
     conditions for which there is no existing treatment;
       ``(E) conditions not included in the recommended uniform 
     screening panel that are treatable with Food and Drug 
     Administration-approved products or other safe and effective 
     treatments, as determined by scientific evidence and peer 
     review;
       ``(F) minimum standards and related policies and procedures 
     used by State newborn screening programs, such as language 
     and terminology used by State newborn screening programs to 
     include standardization of case definitions and names of 
     disorders for which newborn screening tests are performed;
       ``(G) quality assurance, oversight, and evaluation of State 
     newborn screening programs, including ensuring that tests and 
     technologies used by each State meet established standards 
     for detecting and reporting positive screening results;
       ``(H) public and provider awareness and education;
       ``(I) the cost and effectiveness of newborn screening and 
     medical evaluation systems and intervention programs 
     conducted by State-based programs;
       ``(J) identification of the causes of, public health 
     impacts of, and risk factors for heritable disorders; and
       ``(K) coordination of surveillance activities, including 
     standardized data collection and reporting, harmonization of 
     laboratory definitions for heritable disorders and testing 
     results, and confirmatory testing and verification of 
     positive results, in order to assess and enhance monitoring 
     of newborn diseases.''; and
       (2) in subsection (c)(2)--
       (A) by redesignating subparagraphs (E), (F) and (G) as 
     subparagraphs (F), (H), and (I);
       (B) by inserting after subparagraph (D) the following:
       ``(E) the Commissioner of the Food and Drug 
     Administration;''; and
       (C) by inserting after subparagraph (F), as so 
     redesignated, the following:
       ``(G) individuals with expertise in ethics and infectious 
     diseases who have worked and published material in the area 
     of newborn screening;''; and
       (3) by adding at the end the following:
       ``(d) Decision on Recommendations.--
       ``(1) In general.--Not later than 180 days after the 
     Advisory Committee issues a recommendation pursuant to this 
     section, the Secretary shall adopt or reject such 
     recommendation.
       ``(2) Pending recommendations.--The Secretary shall adopt 
     or reject any recommendation issued by the Advisory Committee 
     that is pending on the date of enactment of the Newborn 
     Screening Saves Lives Act of 2007 by not later than 180 days 
     after the date of enactment of such Act.
       ``(3) Determinations to be made public.--The Secretary 
     shall publicize any determination on adopting or rejecting a 
     recommendation of the Advisory Committee pursuant to this 
     subsection, including the justification for the 
     determination.
       ``(e) Annual Report.--Not later than 3 years after the date 
     of enactment of the Newborn Screening Saves Lives Act of 
     2007, and each fiscal year thereafter, the Advisory Committee 
     shall--
       ``(1) publish a report on peer-reviewed newborn screening 
     guidelines, including follow-up and treatment, in the United 
     States;
       ``(2) submit such report to the appropriate committees of 
     Congress, the Secretary, the Interagency Coordinating 
     Committee established under Section 1114, and the State 
     departments of health; and
       ``(3) disseminate such report on as wide a basis as 
     practicable, including through posting on the internet 
     clearinghouse established under section 1112.
       ``(f) Continuation of Operation of Committee.--
     Notwithstanding section 14 of the Federal Advisory Committee 
     Act (5 U.S.C. App.), the Advisory Committee shall continue to 
     operate during the 5-year period beginning on the date of 
     enactment of the Newborn Screening Saves Lives Act of 2007.
       ``(g) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section, 
     $1,000,000 for fiscal year 2008, $1,012,500 for fiscal year 
     2009, $1,025,000 for fiscal year 2010, $1,037,500 for fiscal 
     year 2011, and $1,050,000 for fiscal year 2012.''.

     SEC. 5. INFORMATION CLEARINGHOUSE.

       Part A of title XI of the Public Health Service Act (42 
     U.S.C. 300b-1 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 1112. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.

       ``(a) In General.--The Secretary, acting through the 
     Administrator of the Health Resources and Services 
     Administration (referred to in this part as the 
     `Administrator'), in consultation with the Director of the 
     Centers for Disease Control and Prevention and the Director 
     of the National Institutes of Health, shall establish and 
     maintain a central clearinghouse of current educational and 
     family support and services information, materials, 
     resources, research, and data on newborn screening to--
       ``(1) enable parents and family members of newborns, health 
     professionals, industry representatives, and other members of 
     the public to increase their awareness, knowledge, and 
     understanding of newborn screening;
       ``(2) increase awareness, knowledge, and understanding of 
     newborn diseases and screening services for expectant 
     individuals and families; and
       ``(3) maintain current data on quality indicators to 
     measure performance of newborn screening, such as false-
     positive rates and other quality indicators as determined by 
     the Advisory Committee under section 1111.

[[Page 5392]]

       ``(b) Internet Availability.--The Secretary, acting through 
     the Administrator, shall ensure that the clearinghouse 
     described under subsection (a)--
       ``(1) is available on the Internet;
       ``(2) includes an interactive forum;
       ``(3) is updated on a regular basis, but not less than 
     quarterly; and
       ``(4) provides--
       ``(A) links to Government-sponsored, non-profit, and other 
     Internet websites of laboratories that have demonstrated 
     expertise in newborn screening that supply research-based 
     information on newborn screening tests currently available 
     throughout the United States;
       ``(B) information about newborn conditions and screening 
     services available in each State from laboratories certified 
     under subpart 2 of part F of title III, including information 
     about supplemental screening that is available but not 
     required, in the State where the infant is born;
       ``(C) current research on both treatable and not-yet 
     treatable conditions for which newborn screening tests are 
     available;
       ``(D) the availability of Federal funding for newborn and 
     child screening for heritable disorders including grants 
     authorized under the Newborn Screening Saves Lives Act of 
     2007; and
       ``(E) other relevant information as determined appropriate 
     by the Secretary.
       ``(c) Nonduplication.--In developing the clearinghouse 
     under this section, the Secretary shall ensure that such 
     clearinghouse minimizes duplication and supplements, not 
     supplants, existing information sharing efforts.
       ``(d) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section, 
     $2,500,000 for fiscal year 2008, $2,531,250 for fiscal year 
     2009, $2,562,500 for fiscal year 2010, $2,593,750 for fiscal 
     year 2011, and $2,625,000 for fiscal year 2012.''.

     SEC. 6. LABORATORY QUALITY AND SURVEILLANCE.

       Part A of title XI of the Public Health Service Act (42 
     U.S.C. 300b-1 et seq.), as amended by section 5, is further 
     amended by adding at the end the following:

     ``SEC. 1113. LABORATORY QUALITY.

       ``(a) In General.--The Secretary, acting through the 
     Director of the Centers for Disease Control and Prevention 
     and in consultation with the Advisory Committee on Heritable 
     Disorders in Newborns and Children established under section 
     1111, shall provide for--
       ``(1) quality assurance for laboratories involved in 
     screening newborns and children for heritable disorders, 
     including quality assurance for newborn-screening tests, 
     performance evaluation services, and technical assistance and 
     technology transfer to newborn screening laboratories to 
     ensure analytic validity and utility of screening tests; and
       ``(2) appropriate quality control and other performance 
     test materials to evaluate the performance of new screening 
     tools.
       ``(b) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated $5,000,000 for fiscal year 2008, $5,062,500 for 
     fiscal year 2009, $5,125,000 for fiscal year 2010, $5,187,500 
     for fiscal year 2011, and $5,250,000 for fiscal year 2012.

     ``SEC. 1114. INTERAGENCY COORDINATING COMMITTEE ON NEWBORN 
                   AND CHILD SCREENING.

       ``(a) Purpose.--It is the purpose of this section to--
       ``(1) assess existing activities and infrastructure, 
     including activities on birth defects and developmental 
     disabilities authorized under section 317C, in order to make 
     recommendations for programs to collect, analyze, and make 
     available data on the heritable disorders recommended by the 
     Advisory Committee on Heritable Disorders in Newborns and 
     Children under section 1111, including data on the incidence 
     and prevalence of, as well as poor health outcomes resulting 
     from, such disorders; and
       ``(2) make recommendations for the establishment of 
     regional centers for the conduct of applied epidemiological 
     research on effective interventions to promote the prevention 
     of poor health outcomes resulting from such disorders as well 
     as providing information and education to the public on such 
     effective interventions.
       ``(b) Establishment.--The Secretary shall establish an 
     Interagency Coordinating Committee on Newborn and Child 
     Screening (referred to in this section as the `Interagency 
     Coordinating Committee') to carry out the purpose of this 
     section.
       ``(c) Composition.--The Interagency Coordinating Committee 
     shall be composed of the Director of the Centers for Disease 
     Control and Prevention, the Administrator, the Director of 
     the Agency for Healthcare Research and Quality, and the 
     Director of the National Institutes of Health, or their 
     designees.
       ``(d) Activities.--The Interagency Coordinating Committee 
     shall--
       ``(1) report to the Secretary and the appropriate 
     committees of Congress on its recommendations related to the 
     purpose described in subsection (a); and
       ``(2) carry out other activities determined appropriate by 
     the Secretary.
       ``(e) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated $1,000,000 for fiscal year 2008, $1,012,500 for 
     fiscal year 2009, $1,025,000 for fiscal year 2010, $1,037,500 
     for fiscal year 2011, and $1,050,000 for fiscal year 2012.''.

     SEC. 7. CONTINGENCY PLANNING.

       Part A of title XI of the Public Health Service Act (42 
     U.S.C. 300b-1 et seq.), as amended by section 6, is further 
     amended by adding at the end the following:

     ``SEC. 1115. NATIONAL CONTINGENCY PLAN FOR NEWBORN SCREENING.

       ``(a) In General.--Not later than 180 days after the date 
     of enactment of this section, the Secretary, acting through 
     the Director of the Centers for Disease Control and 
     Prevention and in consultation with the Administrator and 
     State departments of health (or related agencies), shall 
     develop a national contingency plan for newborn screening for 
     use by a State, region, or consortia of States in the event 
     of a public health emergency.
       ``(b) Contents.--The contingency plan developed under 
     subsection (a) shall include a plan for--
       ``(1) the collection and transport of specimens;
       ``(2) the shipment of specimens to State newborn screening 
     laboratories;
       ``(3) the processing of specimens;
       ``(4) the reporting of screening results to physicians and 
     families;
       ``(5) the diagnostic confirmation of positive screening 
     results;
       ``(6) ensuring the availability of treatment and management 
     resources;
       ``(7) educating families about newborn screening; and
       ``(8) carrying out other activities determined appropriate 
     by the Secretary.

     ``SEC. 1116. HUNTER KELLY RESEARCH PROGRAM.

       ``(a) Newborn Screening Activities.--
       ``(1) In general.--The Secretary, in conjunction with the 
     Director of the National Institutes of Health and taking into 
     consideration the recommendations of the Advisory Committee, 
     may continue carrying out, coordinating, and expanding 
     research in newborn screening (to be known as `Hunter Kelly 
     Newborn Screening Research Program') including--
       ``(A) identifying, developing, and testing the most 
     promising new screening technologies, in order to improve 
     already existing screening tests, increase the specificity of 
     newborn screening, and expand the number of conditions for 
     which screening tests are available;
       ``(B) experimental treatments and disease management 
     strategies for additional newborn conditions, and other 
     genetic, metabolic, hormonal and or functional conditions 
     that can be detected through newborn screening for which 
     treatment is not yet available; and
       ``(C) other activities that would improve newborn 
     screening, as identified by the Director.
       ``(2) Additional newborn condition.--For purposes of this 
     subsection, the term `additional newborn condition' means any 
     condition that is not one of the core conditions recommended 
     by the Advisory Committee and adopted by the Secretary.
       ``(b) Funding.--In carrying out the research program under 
     this section, the Secretary and the Director shall ensure 
     that entities receiving funding through the program will 
     provide assurances, as practicable, that such entities will 
     work in consultation with the appropriate State departments 
     of health, and, as practicable, focus their research on 
     screening technology not currently performed in the States in 
     which the entities are located, and the conditions on the 
     uniform screening panel (or the standard test existing on the 
     uniform screening panel).
       ``(c) Reports.--The Director is encouraged to include 
     information about the activities carried out under this 
     section in the biennial report required under section 403 of 
     the National Institutes of Health Reform Act of 2006. If such 
     information is included, the Director shall make such 
     information available to be included on the Internet 
     Clearinghouse established under section 1112.
       ``(d) Nonduplication.--In carrying out programs under this 
     section, the Secretary shall minimize duplication and 
     supplement, not supplant, existing efforts of the type 
     carried out under this section.
       ``(e) Peer Review.--Nothing in this section shall be 
     construed to interfere with the scientific peer-review 
     process at the National Institutes of Health.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentlewoman from 
California (Mrs. Capps) and the gentleman from Georgia (Mr. Deal) each 
will control 20 minutes.
  The Chair recognizes the gentlewoman from California.


                             General Leave

  Mrs. CAPPS. Madam Speaker, I ask unanimous consent that all Members 
may have 5 legislative days to revise and extend their remarks and 
include extraneous material on the bill under consideration.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentlewoman from California?

[[Page 5393]]

  There was no objection.
  Mrs. CAPPS. Madam Speaker, I rise in strong support of Senate bill 
1858, the Newborn Screening Saves Lives Act. This legislation would 
facilitate the creation of Federal guidelines on newborn screening and 
would assist State newborn screening programs in meeting these 
guidelines.
  Newborn screening is used for early identification of infants 
affected by certain genetic, metabolic, hormonal, and functional 
conditions for which there may be an effective treatment or 
intervention. If left untreated, these disorders can cause death, 
disability, mental retardation and other serious conditions. Every 
year, more than 4 million infants are born and screened to detect 
conditions that could threaten their lives and their long-term health.
  Senate bill 1858 will educate parents and health care providers about 
newborn screening. It will improve follow-up care for infants when 
illness is detected, and it will help States expand and improve their 
newborn screening programs.
  It is very important to note that the House Committee on Energy and 
Commerce held a markup of House companion legislation H.R. 3825, which 
was introduced by my colleague, Lucille Roybal-Allard. And I want to 
say a word of commendation toward Lucille Roybal-Allard, who has really 
worked diligently over quite a period of time to make sure that this 
bill reached the floor today. She couldn't be here to speak on behalf 
of the legislation, but I know that there has been a great deal of 
leadership that has brought us to this point today.
  The House Energy and Commerce Committee amended H.R. 3825 to ensure 
that it was identical to the Senate bill, 1858, which has already 
passed the Senate by unanimous consent. And so the good work of our 
friend, Congresswoman Roybal-Allard, has brought us to this point and 
to the commitment that I share on this important piece of legislation.
  I appreciate all of her efforts to carry this legislation forward and 
admire her dedication to helping the children and families affected by 
these conditions.
  I urge all of my colleagues to join in support of Senate bill 1858.
  I reserve the remainder of my time.
  Mr. DEAL of Georgia. Madam Speaker, I yield myself such time as I may 
consume.
  Newborn screening can certainly identify children at risk for certain 
metabolic and genetic diseases for which there may be an effective 
treatment. If it is detected early it is certainly a cost-saving way of 
dealing with these problems that can lead to death, disability, mental 
retardation and many other serious conditions.
  Currently, States have differing policies and procedures for doing 
newborn screening. Accurate screening ensures affected babies are 
identified and receive the proper care.

                              {time}  1600

  This legislation establishes a newborn screening education and 
outreach program at the Department of Health and Human Services in 
order to improve newborn screening. Many parents of newborns are not 
aware of the wide variety of screening tests that are available. Thus, 
the legislation would establish a clearinghouse of educational and 
family support and services information on newborn screening in order 
to provide resources for those families.
  This legislation moved through our committee in a bipartisan process 
and the majority and the minority were able to reconcile a few 
differences on the legislation in that committee process. I would ask 
my colleagues to join me in supporting this important bill.
  Madam Speaker, I reserve the balance of my time.
  Mrs. CAPPS. Madam Speaker, I reserve the balance of my time.
  Mr. DEAL of Georgia. Madam Speaker, I am pleased to yield 3 minutes 
to the gentleman from New York (Mr. Reynolds).
  Mr. REYNOLDS. Madam Speaker, I thank the gentleman from Georgia.
  Madam Speaker, as one of the chief sponsors of the Newborn Screening 
Saves Lives Act, I rise today in strong support of Senate 1858 and urge 
its passage. I would like to extend my thanks to Chairman Dingell and 
Ranking Member Barton for working together to get this bill to the 
floor today.
  This bill is a tribute to children and their parents who have had to 
face the pain of experiencing a disease that wasn't caught by newborn 
screening. Each year, over 4 million children are routinely tested at 
birth for genetic disorders. But what so many parents don't realize is 
that the actual number of conditions that their child is screened for 
depends on the State they live in. A child's life in one State should 
never mean more or less than a child's life in another.
  Every child born with a disease, whether it is common or rare, should 
receive early diagnosis and treatment. That is why we need the Newborn 
Screening Laws Saves Lives Act signed into law and adequately funded. 
Through this legislation, we cannot only educate parents about 
lifesaving tests available for their newborn child, but greatly expand 
the screening programs at the State level.
  Left untreated, many disorders are life-threatening or can cause 
serious mental and physical disabilities. Early detection through 
screening can lessen effects or even completely prevent progression of 
many disorders by providing for immediate medical intervention.
  My State of New York has long been a national leader in newborn 
screening, starting in 1960 when Dr. Robert Guthrie developed the first 
newborn screening tests in Buffalo, New York. New York now tests each 
child for 44 different conditions.
  In 2004, the American College of Medical Genetics completed a report 
commissioned by the U.S. Department of Health and Human Services which 
recommended at a minimum every baby born in the United States be 
screened for a core set of 29 treatable disorders. Currently, only 19 
States and the District of Columbia require infants to be screened for 
all 29 of the recommended disorders. It is my sincere hope through 
grants and research funding provided for in the Newborn Screening Saves 
Lives Act, every State will be able to coordinate their newborn 
screening tests in order to bring consistency across the country.
  Finally, I would like to acknowledge the strong bipartisan efforts of 
my colleagues Lucille Roybal-Allard, Mike Simpson, and Henry Waxman. 
They have long fought for life saving changes to newborn screening it, 
and it has been a pleasure working with them to achieve its 
consideration today.
  I would like to thank Jill and Jim Kelly and Jacque Waggoner from 
Western New York for their tireless advocacy on behalf of enhanced 
newborn screening and for the tremendous efforts to raise public 
awareness about this vital issue.
  Madam Speaker, I urge a ``yes'' vote on the bill.
  Mr. DEAL of Georgia. Madam Speaker, I have no other requests for 
time. I urge the adoption of the resolution, and I yield back the 
balance of my time.
  Mr. PAUL. Madam Speaker, as an OB-GYN I take a back seat to no one 
when it comes to caring about the health of newborn children. However, 
as a Representative who has taken an oath to uphold the Constitution, I 
cannot support legislation, no matter how much I sympathize with the 
legislation's stated goals, that exceeds the Constitutional limitations 
on Federal power or in any way threatens the liberty of the American 
people. Since S. 1858 violates the Constitution, and may have 
unintended consequences that will weaken the American health care 
system and further erode medical privacy, I must oppose it.
  S. 1858 gives the Federal bureaucracy the authority to develop a 
model newborn screening program. Madam Speaker, the Federal Government 
lacks both the constitutional authority and the competence to develop a 
newborn screening program adequate for a nation as large and diverse as 
the United States. Some will say that the program is merely a guide for 
local hospitals. However, does anyone seriously doubt that, whatever 
the flaws contained in the model eventually adopted by the Federal 
Government, almost every hospital in the country will scrap their own 
newborn screening programs in favor of the Federal model? After all, no 
hospital will want to

[[Page 5394]]

risk losing Federal funding because they did not adopt the ``federally 
approved'' plan for newborn screening. Thus, this bill takes another 
step toward the nationalization of health care.
  As the Federal Government assumes more control over health care, 
medical privacy has increasingly come under assault. Those of us in the 
medical profession should be particularly concerned about policies 
allowing Government officials and State-favored interests to access our 
medical records without our consent. After all, patient confidentiality 
is the basis of the trust that must underline a positive physician-
patient relationship. Yet my review of S. 1858 indicates the drafters 
of the legislation made no effort to ensure these newborn screening 
programs do not violate the privacy rights of parents and children.
  In fact, by directing Federal bureaucrats to create a contingency 
plan for newborn screening in the event of a ``public health'' 
disaster, this bill may lead to further erosions of medical privacy. As 
recent history so eloquently illustrates, politicians are more than 
willing to take, and people are more than willing to cede, liberty 
during times of ``emergency.'' Thus, most people will gladly sacrifice 
their families' medical privacy if they are told it is necessary to 
protect them from a Government-declared health emergency, while the 
Federal Government will be very unlikely to relinquish its new powers 
when the emergency passes.
  I am also skeptical, to say the least, that a top-down Federal plan 
to screen any part of the population will effectively help meet the 
challenges facing the health care system in the event of a real public 
emergency. State and local Governments working together with health 
care providers, can better come up with effective ways to deal with 
public health emergencies than can any Federal bureaucracy. It is for 
these reasons, Madam Speaker, that I oppose S. 1858.
  Mrs. CAPPS. Madam Speaker, I have no further speakers. I urge the 
adoption of S. 1858, the Newborn Screening Saves Lives Act, and yield 
back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentlewoman from California (Mrs. Capps) that the House suspend the 
rules and pass the Senate bill, S. 1858.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the Senate bill was passed.
  A motion to reconsider was laid on the table.

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